1728287121016-Lecture_6_and_7.pdf

TOOLS USED IN PV AND DRUG INFORMATICS Learning By the end of this lecture, students should be able to: Outcomes List the analytical tools used in PV and drug informatics Data mining Among the several statistical techniques covered in data mining, PV analytics will use the fol...

TOOLS USED IN PV AND DRUG INFORMATICS Learning By the end of this lecture, students should be able to: Outcomes List the analytical tools used in PV and drug informatics Data mining Among the several statistical techniques covered in data mining, PV analytics will use the following: Descriptive modelling Diagnostic modelling Predictive modelling Prescriptive modelling & Disproportionality methods Geographic Information Systems (GIS) Text and information mining Visualization tools  Used to uncover shared similarities or Descriptive groupings in historical data to determine reasons behind success or failure. modelling Descriptive analytics tell us what happened, (What why, what’s happening right now, and why. Techniques like “Anomaly –an outlier- happened) detection” and “Principal components analysis” are used here. Diagnostic modelling (Why did it happen) Diagnostic analytics is the process of using data to determine the causes of trends and correlations between variables. It can be viewed as a logical next step after using descriptive analytics to identify trends. Diagnostic analysis can be done manually, with an algorithm or statistical software (such as Microsoft Excel). The important aspects here are hypothesis testing and the difference between correlation and causation. Predictive modelling (What will happen) Used to classify events in the future or estimate unknown outcomes. Predictive analytics will tell us what is likely to happen, and why. Techniques in this domain are: Tools like “Decision trees” help here.  Prescriptive modelling, which is also called “the last frontier of analytic capabilities”, takes information from descriptive and predictive analytics Prescriptive and combines it with information obtained from unstructured data (text modelling (How mining, web mining) for improved prediction accuracy. can we make it Prescriptive modeling looks at internal and external variables and constraints, happen) to recommend one or more courses of action. Prescriptive analytics can tell us what our options are, and what we should do.  Disproportionality methods, specific to patient safety, are used to identify statistical associations between products and events. Such methods compare the observed count for a Disproportionality product-event combination with an expected count. methods The expected counts can be obtained from large public databases like FAERS for drug-event combinations. Reporting odds ratio (ROR) is the foundational concept for many disproportionality methods. FDA Adverse Event Reporting System (FAERS)  GIS can be used to identify geographic trends over time, perform surveillance, visualize the locations of patients, and determine if there are clusters of specific types of customer or patient experiences. These systems allow for the use of different layers of information. It also provides a method in which we can systematically address where certain events are more likely to occur and implement preventive or corrective measures. Tracking the spread of infectious diseases or performing outbreak investigations are well-known uses of GIS. Another interesting layer of information will be incorporating social media: it can play a significant role, as in the case of tweets informing of healthcare-related Geographic issues in relation to patients on company medicinal products. Information Tracking potential safety problems with GIS can provide new opportunities for real-time interventions, and identification of patients at risk, patterns, and areas Systems (GIS) where patient education and assistance may be adequate. GIS allows us to visualize, question, analyze, interpret, and understand data to reveal relationships, patterns, and trends, perform surveillance and documentation of the geographic components of the diseases targeted by the company and its risk factors, and can help with disease prevention programs and policies.  An important part of the AE reporting is unstructured (narratives, event descriptions), as Text and well as the information obtained information from the Internet. Text and information mining help mining to detect specific text patterns or combinations, as well as trends.  Visualization analytics encompasses the use of pictures and graphics to facilitate the understanding of complex data relationships by displaying data in a visually meaningful way. Visualization Very useful and fundamental tools instrument for visualizing patterns in the environment of multiple-source data integration. Widely used in healthcare data analytics.  DOMESTIC AND GLOBAL REGULATORY REQUIREMENTS  Learning Outcomes By the end of this lecture, students should be able to: Explain the domestic and global regulatory requirements  The role of regulatory authorities is a public health function Pharmaceutical companies also have similar duties but they have an additional, commercial function as well. Both parties are obliged to operate pharmacovigilance systems, exchange data, and, where necessary, take appropriate action to protect Introduction patients. General role of the SFDA The role of the SFDA is to coordinate the monitoring of medicinal products for human use authorized in KSA to provide advice on the measures necessary to ensure their safe and effective use, in particular, by coordinating the evaluation and implementation of legal pharmacovigilance requirements and the monitoring of such implementation.  The SFDA shall put in place the following additional specific quality system processes: Monitoring and validating the use of terminology referred to either systematically or by regular random evaluation. Assessing and processing pharmacovigilance data by the timelines provided by the legislation; Specific quality Ensuring effective communication within the SFDA by the provisions on safety announcements ; system processes Arranging for the essential documents describing their of the quality pharmacovigilance systems to be kept as long as the system exists and for at least a further 5 years after they have been systems of the formally terminated. SFDA Ensuring that pharmacovigilance data and documents relating to individual authorized medicinal products are retained as long as the marketing authorization exists or for at least a further 10 years after the marketing authorization has expired.  The pharmacovigilance systems of marketing authorization holders, the SFDA should be adaptable to public health emergencies. Preparedness A public health emergency is a public health threat duly recognized either by planning in KSA for the World Health Organization (WHO) pharmacovigilance or the Saudi Health Authorities. in public health Pharmacovigilance requirements for public health emergencies should be emergencies considered by the SFDA on a case-by- case basis and appropriately notified to marketing authorization holders and the public. The SFDA publishes its notifications on the SFDA website.  The WHO’s international collaborative program on drug safety was originally set up in 1968. Their monitoring center is now based in Uppsala, Sweden. The main activities of the center are as follows: The WHO’s Co-ordinating the WHO Programme for international International Drug Monitoring Collecting, assessing, and communicating information from member countries about the benefits collaborative and risks of drugs Programme Collaborating with member countries in the development and practice of pharmacovigilance. Alerting regulatory authorities of member countries about potential drug safety problems.  Information is exchanged between WHO and the national centers electronically through ‘Vigimed’. The Uppsala Monitoring Centre also publishes periodic newsletters and is responsible for managing the WHO Drug Dictionary and the WHO Adverse Reaction Terminology (WHOART). How it works The Centre also provides training and support to countries establishing pharmacovigilance systems, particularly in the developing world. There is an annual meeting of representatives of collaborating centers at which scientific and organizational matters are discussed.  The CIOMS is based in Geneva and operates under the WHO umbrella. It has served as a forum for Council for the discussions between regulators and Organization of industry on a variety of pharmacovigilance topics since the Medical late 1980s. Sciences Over the years, reports from CIOMS working groups have been highly (CIOMS) influential in shaping legislation and guidelines around the world.  The International Conference on Harmonization (ICH) is a more formal group than CIOMS with a wider remit for harmonization across the drug development process. It has also been influential in shaping current International regulatory requirements pharmacovigilance. relating to Conference on ICH involves representatives from regulators Harmonisation and industry and is tripartite in terms of regions, covering the EU, USA, and Japan. There are also various observers, e.g. from the WHO. The main purpose is to harmonize existing guidelines from the three regions related to the development and registration of medicines.  ICH guidelines In principle, the authorities in each territory are committed to implementing ICH, guidelines although, in practice, the timing and extent of implementation have been variable. There are four broad categories of ICH guidelines, as follows: a. Quality (Q) b. Safety (S) c. Efficacy (E) d. Multidisciplinary (M) In relation to pharmacovigilance, the key ICH guidelines, and the dates on which they were implemented are: E2A: Definitions and Standards for Expedited Reporting (1994) E2B: Data Elements for Electronic transmission of Individual Case Safety Reports (1997) E2C: Periodic Safety Update Reports for Marketed Drugs (1996) E2D: Post-approval Safety Data Management (2003) E2E: Pharmacovigilance Planning (2005) The MedDRA was originally developed through the ICH process. More information on ICH will be discussed in next class Thank you